ImmunoBiology recently reported positive data from its first in human clinical trial (NCT02572635) on PnuBioVax, a vaccine targeting pneumococcal disease that utilizes the company’s ImmBioVax technology.
Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain. The elderly and young children are more vulnerable to these types of infections.
The vaccines available at present are effective only on a certain number of strains of the bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains.
The Phase I clinical trial evaluated the safety and immunogenicity of PnuBioVax administered on three occasions in dosages of 50 μg, 200 μg, and 500 μg, compared to placebo. The doses were given 28 days apart to 36 healthy adults.
The study showed PnuBioVax to be safe and well tolerated, and producing antibody responses against key S. pneumoniae antigens across strains. The safety data concluded that no clinically significant changes of vital signs, ECG, or blood chemistries were observed as a result of treatment with the vaccine.
There was a statistically significant increase in total antibody response seen in the 200 and 500 µg dose groups compared to placebo, showing PnuBioVax to be immunogenic.
These results were presented by ImmunoBiology Development Director Chris Bailey at the 10th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD), held in Glasgow, U.K.
“The results of this study have demonstrated the safety of PnuBioVax in adults, and we are now looking at developing the vaccine further, focusing on the at-risk populations for pneumococcal disease of the young and the elderly,” Bailey said.
Graham Clarke, the company’s CEO, said the vaccine is a fundamental step in the company’s mission to create a universal vaccine against pneumococcal disease.
“This provides the real prospect of a strain-independent pneumococcal disease prophylactic vaccine. We are now looking for partners to progress PnuBioVax through late stage clinical development, manufacturing and marketing,” Clarke said.